Response Biomedical Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Response Biomedical Corp.” (first 2001, latest 2009), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 168 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 2 | 2 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 1 | 1 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 | 1 |
| JHX | Fluorometric Method, Cpk Or Isoenzymes | 1 | 1 |
| MMI | Immunoassay Method, Troponin Subunit | 1 | 1 |
| NBC | Test, Natriuretic Peptide | 1 | 1 |
Review panels
- Clinical Chemistry (3)
- Microbiology (3)
- Immunology (1)
Most recent Response Biomedical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093116 | MODIFICATION TO: RAMP INFLUENZA A/B ASSAY | PSZ | 2009-10-21 | 19 |
| K091235 | RAMP RSV ASSAY | GQG | 2009-07-24 | 88 |
| K063662 | RAMP NT-PROBNP ASSAY | NBC | 2008-07-21 | 591 |
| K071591 | RAMP INFLUENZA A/B ASSAY | PSZ | 2008-04-16 | 310 |
| K033747 | RAMP CK-MB ASSAY | JHX | 2004-05-17 | 168 |
| K033745 | RAMP TROPONIN I ASSAY | MMI | 2004-05-17 | 168 |
| K012040 | RAMP MYOGLOBIN ASSAY | DDR | 2001-12-18 | 172 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-03-15.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Response Biomedical Corp. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02191735: RAMP 200 / RAMP Cardiovascular Tests at the Point-of-Care (Completed, started 2014-07)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Response Biomedical Corp. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Response Ortho Solutions, LLC (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Response Biomedical Corp.?
FDA lists 7 510(k) clearances under the applicant name “Response Biomedical Corp.” (first 2001, latest 2009), across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Response Biomedical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Response Biomedical Corp. is 168 days.
Which FDA product codes appear under Response Biomedical Corp.?
The most frequent FDA product codes under this applicant name are PSZ (Devices Detecting Influenza A, B, And C Virus Antigens, 2); DDR (Myoglobin, Antigen, Antiserum, Control, 1); GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus, 1).
Next steps
- See all 7 Response Biomedical Corp. clearances with predicates and recalls
- Run predicate analysis for product code PSZ, Response Biomedical Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.